Future of bio-manufacturing
The future of biomanufacturing is highly dependent on the current trends of pharmaceutical industry where a number of innovations have flourished over the recent few years. Beginning from a small-molecule success ratio, the pharmaceutical manufacturing has seen its highs and lows with the discovery of a vast variety of drugs and new facilities. Even though the industry is in the successful era of its development, there are still a wide number of factors in the biopharmaceutical manufacturing that still remain untouched by the challenges facing the industry as a whole. Before delving into prospects of bio-manufacturing, a sneak peak of current treatment employed in manufacturing industries is very necessary. As of today’s trend whether it is the manufacturing of hormones, recombinant proteins or monoclonal antibodies, the drug makers have developed a habit of setting up biological factories.
Studies on relevant and productive bio-manufacturing facilities possess the dominance of bioreactors stretched out as a medium to improvise many factors such as cell growth and the downstream equipment for harvesting, purifying and concentrating drugs. Considering various sources for a huge number of bio-manufacturing testing techniques, the ongoing trend makers have diverted their concentration on only current facilities that are largely available for emerging biopharmaceuticals. It has also paved a path to concentrate on just one product to avoid cross-contamination. Experts have listed these trends in the present to be more innovative and evolving to better match in today’s technological opportunities and new drugs.
One cannot deny the fact that the prospect of the bio-manufacturing facility will be highly dependent on the biopharmaceutical drugs of the future. A recent statistical report shows that there are more than 3000 pharmaceutical drugs in operation and close to 6000 are in preclinical or discovery stage and 4000 drugs are actively progressing in clinical development. It has been observed that, the biggest research and development consists of more than 4000 products existing in the cancer space alone. However, only the number of products in oncology is set to increase dramatically when compared to the other products. In the recent years, leading pharmaceutical manufacturing industries showcased an increased understanding of the complex interplay existing between cellular, genetic and environmental factors. This has lead to the discovery of as many different cancers as there are patients. For instance, there are 25% of patients with tumor that overexpose HER2 (2) and the drug trastuzumab is used treatment of this type of breast cancer. The cost estimated to arrange a whole human genome sequence is now less than $1000. Invariably, the treatment takes very few hours.
Yet another significant trend in bio-manufacturing is biosimilars which are the first erythropoietin, granulocyte colony stimulating factor. Drugs such as trastuzumab have been tumbled off the patient cliff. Biosimilars are not necessarily as straight forward as small-molecule drugs to manufacture. When analyzing the molecular structure of biopharmaceutical drugs, it is found that the relative genetic background of the cell line used has a greater impact on the translational modifications such as glycosylation. Since each of the cell lines belongs to exclusive property of the company, biosimilar organizations hold the responsibility of manifesting the efficacy of toxicological studies and clinical double-blinded studies in order to prove the similarity of biosimilar products with respect to its originator.
The added future of the bio-manufacturing industry is heavily based on continuous research and development in terms of timing. Even though, the focus shall be concentrated on small molecules, the overall concept should follow through to biologics. A part of Sanofi called Genzyme is on the working progress of continuous processing for quite a long time. More number of extensive researches is persistently needed to cope up with the public and with the industry.
